Implantable component with socket

ABSTRACT

Implantable devices may include a single, first component or a plurality of components such as first and second components, the second component being flexibly coupled to the first component. A socket extends over one or more of the component(s), the socket being configured to enhance the inter-component interaction and/or including one or more exposed surface(s) configured to exhibit one or more tiers of foreign body responses within a range of possible foreign body responses.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of Provisional Application No.62/778,654, filed Dec. 12, 2018, which is incorporated herein byreference in its entirety for all purposes.

FIELD

The present disclosure relates generally to covers, receptacles,shrouds, couplers, constrainers and the like (collectively, sockets) forimplantable medical devices, and more specifically sockets configured toenhance inter-component and/or inter-environment interactions of animplantable device.

BACKGROUND

Implantable device components are implemented in a variety of contexts,such as transcatheter mitral chordal repair devices. Improvements in theinteractions between a plurality of device components in vivo, as wellas interactions between the plurality of device components and thebodily environment remain to be realized.

SUMMARY

Various examples relate to an implantable medical device (e.g., atranscatheter mitral chordal device) that includes a first component(e.g., an anchor component) and a second component coupled to the firstcomponent (e.g., a tether component). Interactions (e.g., relativemovement, flexing, abrading, or other mechanical interactions) betweenthe first and second components may benefit from being controlled (e.g.,minimized) and interactions between the first and/or second componentsand the bodily environment may be enhanced (e.g., by encouraging tissueingrowth and/or minimizing thrombosis). In further examples,interactions between the first and/or second components and a thirdcomponent (e.g., a tether lock component) are improved (e.g., byreducing relative movement and/or facilitating inter-component docking),and interactions between the third component and the bodily environmentare improved (e.g., by encouraging tissue ingrowth and/or minimizingthrombosis). Various examples provided herein relate to covers,receptacles, shrouds, couplers, constrainers, retaining members and thelike (collectively referred to herein as, “sockets”) for enhancing suchinter-component and inter-environment interactions of an implantabledevice.

According to a first example, (“Example 1”), an implantable deviceincludes a first component; a second component flexibly coupled to thefirst component; and a socket extending over the first component and thesecond component, the socket being configured to enhance theinter-component interaction between the first and second components ofthe implantable device by reducing relative movement between the firstand second components, wherein the socket includes one or more outerexposed surface(s) configured to exhibit one or more tiers of foreignbody responses within a range of possible foreign body responses.

According to another example, (“Example 2”), further to Example 1, theone or more outer exposed surfaces is configured to exhibit a foreignbody response including extracellular matrix integration.

According to another example, (“Example 3”), further to any precedingExample, the socket includes one or more layers of material that isimpermeable to cellular integration.

According to another example, (“Example 4”), further to any precedingExample, the socket includes one or more layers of material having amicrostructure that is oriented to provide longitudinal strength to oneor more portions of the socket.

According to another example, (“Example 5”), further to any precedingExample, the socket includes one or more layers of material having amicrostructure that is oriented to provide circumferential strength toone or more portions of the socket.

According to another example, (“Example 6”), further to any precedingExample, the socket includes one or more reinforcing rings.

According to another example, (“Example 7”), further to Example 6 atleast one of the one or more reinforcing rings is elastically deformableto an enlarged diameter from which the one or more reinforcing ringselastically recovers.

According to another example, (“Example 8”), further to Examples 6 or 7,the one or more reinforcing rings defines a continuous, helicalundulating pattern.

According to another example, (“Example 9”), further to any precedingExample, the socket includes an outwardly flared end.

According to another example, (“Example 10”), further to any precedingExample, the socket includes a reinforced end.

According to another example, (“Example 11”), further to any precedingExample, the first component is an anchor component and the secondcomponent is a tether component.

According to another example, (“Example 12”), further to any precedingExample, the implantable device of any preceding claim, furthercomprising a third component and fourth component, the socket beingconfigured to receive the third and fourth components to enhance theinter-component interaction between the first and third components ofthe implantable device.

According to another example, (“Example 13”), further to Example 12, thethird component is a tether lock component and the fourth component is atether component.

According to another example, (“Example 14”), further to any precedingExample, at least one of an outer and an inner surface of the socketincludes material configured to promote tissue ingrowth.

According to another example, (“Example 15”), further to any precedingExample, the socket is formed of one or more layers of materialincluding a film microstructure in which fibrillar orientation is in adirection aligned to a longitudinal axis of socket.

According to another example, (“Example 16”), further to any precedingExample, the socket is formed from a material set including ePTFE graftmaterial, elastomer material, other polymeric material, or a combinationof two or more such materials.

According to another example, (“Example 17”), further to any precedingExample, the socket includes an ePTFE stretch graft material.

According to another example, (“Example 18”), further to any precedingExample, the socket includes material that is partially or fullybio-resorbable and/or partially or fully bio-absorbable.

According to another example, (“Example 19”), further to any precedingExample, the socket is configured to provide temporary fixation to bodytissue that degrades partially or fully over time.

According to another example, (“Example 20”), further to any precedingExample, the socket includes one or more layers configured as a mesh ornetwork of material that is adapted to enhance biocompatibility andfibrosis following implantation.

According to another example, (“Example 21”), further to Example, 20,the mesh or network of material is formed by crossing strands ofmaterial or by intermittent voids or openings in one or more layers ofmaterial.

According to another example, (“Example 22”), further to any precedingExample, the implantable device is configured as a transcatheter mitralchordal repair device or a blood pump device.

According to another example, (“Example 23”), a method of treatmentusing the implantable device of any preceding Example includesdelivering the implantable device to a location in a body of a patient.

According to another example, (“Example 24”), further to Example 23, themethod further includes inserting another component, such as the thirdcomponent of Example 12, into the socket in vivo.

According to another Example (“Example 25”), an implantable deviceincludes a first component having a first outer profile defining firstradial variability along the first component and a socket extending overthe first outer profile of the first component to define a second outerprofile having a second radial variability that is reduced relative tothe first radial variability, wherein the socket includes one or moreouter exposed surfaces configured to exhibit one or more tiers offoreign body responses within a range of possible foreign bodyresponses. Any of the features of Examples 1 to 24 may be applicable toExample 25 as appropriate.

According to another Example (“Example 26”), a socket is configured toextend over a first outer profile of a first component of an implantabledevice to define a second outer profile having a second radialvariability that is reduced relative to a first radial variability ofthe first component, wherein the socket includes one or more outerexposed surfaces configured to exhibit one or more tiers of foreign bodyresponses within a range of possible foreign body responses.

According to another Example (“Example 27”), a socket is configured toextend over a first component and a second component of an implantabledevice, the socket being configured to enhance the inter-componentinteraction between the first and second components of the implantabledevice by reducing relative movement between the first and secondcomponents, wherein the socket includes one or more outer exposedsurfaces configured to exhibit one or more tiers of foreign bodyresponses within a range of possible foreign body responses.

According to another Example (“Example 28”), a method includesdelivering a multi-component device to a location in a body of apatient, the multi-component device including a first component having afirst outer profile defining first radial variability along the firstcomponent; and a socket extending over the first outer profile of thefirst component to define a second outer profile having a second radialvariability that is reduced relative to the first radial variability,wherein the socket includes one or more outer exposed surfacesconfigured to exhibit one or more tiers of foreign body responses withina range of possible foreign body responses; and inserting a thirdcomponent into the socket to enhance the inter-component interactionbetween the first and third components of the implantable device.

According to another example (“Example 25”), further to the method ofExample 24, the third component is a tether lock component.

The foregoing Examples are just that and should not be read to limit orotherwise narrow the scope of any of the inventive concepts otherwiseprovided by the instant disclosure. While multiple examples aredisclosed, still other embodiments will become apparent to those skilledin the art from the following detailed description, which shows anddescribes illustrative examples. Any of a variety of additional oralternative features and advantages are contemplated and will becomeapparent with reference to the disclosure and figures that follow.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature rather than restrictive in nature.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments, and together withthe description explain the principles of the disclosure.

FIG. 1 shows an implantable device, according to some examples.

FIGS. 2A and 2B, show an implantable device, according to some examples.

FIGS. 3 to 6 are illustrative of some methods of forming a socket andcoupling the socket to a first component of an implantable device,according to some examples.

FIG. 7 shows features of a socket of an implantable device, according tosome examples.

FIGS. 8 and 9 show features of a socket of an implantable device, aswell as manufacturing methodology, according to some examples.

FIG. 10 shows a manner of assembling a socket to a first component of animplantable device, according to some examples.

FIG. 11 shows an implantable device utilizing a socket, according tosome examples.

FIG. 12 shows an implantable device utilizing a socket, according tosome examples.

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale, but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

DETAILED DESCRIPTION Definitions and Terminology

This disclosure is not meant to be read in a restrictive manner. Forexample, the terminology used in the application should be read broadlyin the context of the meaning those in the field would attribute suchterminology.

The terms “substantially” and “generally” are used in the presentdisclosure to convey a degree of inexactitude as would be understood andreadily ascertainable by a person having ordinary skill in the art.

With respect terminology of inexactitude with reference to measurements,the terms “about” and “approximately” may be used, interchangeably, torefer to a measurement that includes the stated measurement and thatalso includes any measurements that are reasonably close to the statedmeasurement. Measurements that are reasonably close to the statedmeasurement deviate from the stated measurement by a reasonably smallamount as understood and readily ascertained by individuals havingordinary skill in the relevant arts. Such deviations may be attributableto measurement error or minor adjustments made to optimize performance,for example. In the event it is determined that individuals havingordinary skill in the relevant arts would not readily ascertain valuesfor such reasonably small differences, the terms “about” and“approximately” can be understood to mean plus or minus 10% of thestated value.

As used herein, the term “tube” does not require a component with acontinuous wall unless otherwise noted, but can include meshes,frameworks, perforated constructs, annular or ring constructs, and thelike.

As used herein, the term “socket” is inclusive of and may be usedinterchangeably with any of the following terms: covers, receptacles,shrouds, couplers, constrainers, retaining members and the like.

Description of Various Embodiments

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatuses configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale, but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

FIG. 1 shows an implantable device 10, according to some examples. Asshown, the implantable device 10 includes a plurality of components 20,such as a first component 22, a second component 24, and a socket 30extending over the first component 22 and the second component 24. Thesocket 30 is generally configured to enhance inter-component andinter-environment interactions of an implantable device. For ease ofillustration and visualization of the underlying components, the socket30 is illustrated in a see-through manner, designated by broken lines.As shown, the socket 30 is generally in the form of a continuous tube,or cylinder of material although discontinuous tubes, annular tubes, andother tube variations are contemplated.

Although the implantable device 10 is subsequently described withreference to components that may be associated with a transcathetermitral chordal repair device (e.g., such as those disclosed in U.S. Pat.App. Pub. No. 2018/0185151, “METHOD FOR TRANSVASCULAR IMPLANTATION OFNEO CHORDAE TENDINAE,”) similar principles may be applied to any of avariety of implantable devices as desired (see, e.g., FIG. 11 andassociated description).

As shown, in some examples the first component 22 is configured as ananchor component having a body 40 and a barb 42. In some examples, thebody component is configured to be delivered endoluminally (e.g., viatranscatheter technique) and is formed of a biocompatible metal orpolymeric material, for example. The barb 42 may be formed of the same,similar or different material from the body 40 and is configured to berotated, or screwed into tissue (e.g., cardiac tissue, such as thatassociated with the ventricular wall of a heart). In turn, the secondcomponent 24 may be configured as a tether component formed of arelatively flexible, elongate material (e.g., monofilament,multifilament, braided, or other material). In some examples, the secondcomponent is formed of expanded polytetrafluoroethylene (ePTFE),although any of a variety of materials may be used as desired. Althoughthe barb 42 is shown as a helical, screw type anchor, it should beunderstood that any of a variety of anchoring or engagement features maybe substituted for the barb 42 or added in addition to the barb 42. Forexample, needles, arrow-shaped barbs, expanding coils or umbrella-typeanchors, pledget tissue anchors, or any of a variety of other tissueanchor designs are contemplated.

As shown in FIG. 1 , the second component 24 is coupled to, and extendsfrom the first component 22. In use, the second component 24 may flex,or deflect naturally following implantation. As shown in FIG. 1 , thesocket 30 extends over the plurality of components 20, including thefirst component 22 and the second component 24. The socket 30 may extendpartially over the plurality of components 20 or completely over theplurality of components 20.

As shown in FIG. 1 , the socket 30 is configured to minimizeflexing/deflection of the second component 24 adjacent to where thesecond component 24 extends from the first component 22. In particular,the socket 30 may be configured to hold the second component 24 (tethercomponent) in position by compressing, sandwiching, guiding, and/orpressing the second component 24 close to the body 40 of the firstcomponent 22 (anchor component). By minimizing relative movement, andpotential wearing/abrading/concentrated flexing at the interface betweenthe first and second components 22, 24, the socket 30 serves to enhancethe inter-component interaction between the first and second components22, 24 of the implantable device 10.

Additionally or alternatively, as subsequently described, the socket 30may be adapted to enhance the inter-environment interaction between thefirst component 22 and the second component 24 and the bodilyenvironment (not shown). For example, the socket 30 may include one ormore coatings, layers, surface treatments, or other enhancementsconfigured to promote tissue ingrowth, inhibit tissue ingrowth, reducethrombosis and combinations thereof in order to promote, or enhancedesirable interactions between the implantable device 10 and the bodilyenvironment in which the implantable device 10 is implanted.

FIGS. 2A and 2B shows further, optional features of the implantabledevice 10. As shown, the plurality of components 20 include a thirdcomponent 26 and a fourth component 28. The third component 26 may beconfigured as an adjustable tether lock component and the fourthcomponent 28 may be configured as a second tether component. The thirdcomponent 26 may be configured to be slid along the second component 24(first tether component) and along the fourth component 28 (secondtether component) and to lock, or arrest further sliding once positionedas desired. Examples of suitable tether lock components are desired inthe previously mentioned U.S. Pat. App. Pub. No. 2018/0185151, “METHODFOR TRANSVASCULAR IMPLANTATION OF NEO CHORDAE TENDINAE,” although any ofa variety of configurations are contemplated. As shown in FIGS. 2A and2B, the third component 26 is configured to be longitudinally slide intothe socket 30 as part of delivery of the implantable device 10.

As shown in FIG. 2B, the socket 30 is configured to minimizeflexing/deflection of the second component 24 adjacent to where thesecond component 24 extends from the first component 22 as previouslydescribed. Additionally, the socket 30 may be configured to similarlyhelp minimize flexing between the third component (tether lock) andfourth component (second tether component) by sandwiching one or moreportions of the fourth component 28 against the third component 26.Moreover, the socket 30 may assist with reducing relative movement(e.g., flexing and/or longitudinal movement) between the first component22 (anchor component) and the third component 26 (tether lockcomponent). In particular, the socket 30 may be configured to hold thethird component 26 in position relative to the first component 22 (e.g.,generally axially aligned and longitudinally proximal and/or engaging)and reduce the amount of flexing or shifting between the two. Byminimizing relative movement, and potentialwearing/abrading/concentrated flexing between the plurality ofcomponents 20, the socket 30 again serves to enhance the inter-componentinteraction of the implantable device 10. Additionally or alternatively,as previously referenced and subsequently described in greater detail,the socket 30 may be adapted to enhance the inter-environmentinteraction between one or more of the plurality of components 20 andthe body of a patient, or bodily environment.

FIGS. 3 to 6 are illustrative of some methods of forming the socket 30and coupling the socket 30 to the first component 22, according to someexamples.

Some methods include forming a precursor tube 100 that is then formedinto the socket 30. Thus, some methods of manufacture include firstproviding the precursor tube 100. The precursor tube 100 may be formedusing wrapping techniques (e.g., tape material that is helically wrappedonto a mandrel to form the precursor tube 100 and/or sheet material thatis cigarette wrapped onto a mandrel), extrusion techniques, moldingtechniques, combinations thereof, or other manufacturing techniques asdesired. The precursor tube may be formed as a monolayer or multi-layerconstruct as desired. The precursor tube 100 may be formed of any of avariety of materials using any of a variety of methods, including any ofthose previously described. In one example, the precursor tube 100includes one or more layers of fluoropolymer (e.g., ePTFE) material. Theprecursor tube 100 may generally be in the form of a hollow rightcylinder, may include tapers or steps, or may have any of a variety ofadditional or alternative features. As shown in FIG. 3 , the precursortube 100 is generally elongate, defines a length, and includes an openinner lumen into which the first component 22 may be received.

Some methods of forming the socket 30 and coupling the socket 30 to thefirst component 22 can be understood with reference starting at FIG. 3 .As shown in FIG. 3 , the precursor tube 100 is received over the body 40of the first component 22. Then, as shown in FIG. 4 , a retainer 102 maybe received over the precursor tube and the body 40, with the retain 102received in a complementary feature (e.g., a recess) formed into thebody 40. The retainer 102 may be a ring or wrap of material. In someexamples, the retainer 102 may be formed as a continuous ring, orpartial ring of fluorinated ethylene propylene (FEP), although a varietyof materials and physical configurations are contemplated.

As shown in FIG. 5 , one end of the precursor tube 100 may be foldedback over onto itself, such that the precursor tube 100 is everted. Theeverted, precursor tube 100 is then doubled over, forming an innerportion 104 that may include one or more layers of material and an outerportion 106 that may include one or more layers of material. The outerportion overlays the inner portion with the retainer 102 receivedbetween the inner and outer portions.

As shown in FIG. 6 , the precursor tube 100 may then be bonded to itselfand/or the retainer 102 (e.g., by compression, adhesion, sintering,bonding, or combinations thereof). Regardless, FIG. 6 shows theprecursor tube 100 and other materials (i.e., the retainer 102) combinedto form the socket 30, with the socket 30 coupled to the first component22. In some examples, the eversion process, and formation of a doublelayer, helps to achieve a radially compliant structure as well as alongitudinally stiffer (e.g., relatively higher column strength) ascompared to a single layer construct which helps prevent buckling of thesocket 30 in examples where the third component 26 to be inserted intothe socket 30 (e.g., in vivo). Radial compliance can also assist withretention of the third component 26 in the socket 30 (e.g., followinginsertion of the third component 26 into the socket 30).

FIG. 7 shows an additional or alternative feature of the socket 30,according to some examples. For reference, formation of the socket 30according to FIG. 7 does not require use of the manufacturingmethodology described above with regard to FIGS. 3 to 6 , but maycertainly use such techniques as desired. Regardless, as shown in FIG. 7, the socket 30 includes an end 200 that is reinforced and/or outwardlyflared which may facilitate receiving a component (e.g., the thirdcomponent 26) into the socket 30. The end 200 may be reinforced and/orflared with a reinforcement member 202, such as a ring or wrap ofmaterial. In some examples, the reinforcement member 202 is a ring ofmaterial (e.g., FEP) bonded inside to, bonded outside to, or embedded inthe tubular material of the socket 30. The incorporate of an outwardlyflared and/or reinforced end may help ensure that the end 200 helpsguide the third component 26 into the socket 30, that the end 200remains open, and that the end 200 is robust enough to be engaged by thethird component 26 without an unwanted amount of deflection, buckling,and/or folding, for example.

FIGS. 8 and 9 show alternative or additional features of the socket 30,as well as another manufacturing methodology which may be combined withany of the features or manufacturing techniques previously described.

As shown in FIG. 8 , the socket 30 may be formed using wrappingtechniques with an underlying mandrel 300 of a desired diameter. In someexamples, an inner portion 302 is disposed over a mandrel 300. The innerportion 302 may be wrapped (e.g., tape wrapped), extruded, molded orotherwise formed. The inner portion 302 may include one layer or aplurality of layers as desired (e.g., or more passes, or layers ofmaterial). One or more optional reinforcing rings 304 (e.g., formed as acontinuous helical structure or individual ring structures) may beapplied to the inner portion 302 as desired.

The reinforcing rings 304, whether continuous (e.g., continuous helical,undulating pattern) or discontinuous (e.g., discrete, undulatingpattern), may be formed of a material that is elastically deformable(e.g., distensible) such that the one or more reinforcing rings 304 willthen return to its original diameter when an outer radial force isremoved from the reinforcing ring(s) 304. The one or more reinforcingrings 304 can be formed of any suitable material, such as metallicmaterials (e.g., nitinol or stainless steel) or polymeric materials(e.g., elastomers) as desired.

As shown, an outer portion 306 may then be disposed over the innerportion 202 and the one or more reinforcing rings 304. The outer portion306 may be wrapped (e.g., tape wrapped), extruded, molded or otherwiseformed and may be one layer or a plurality of layers as desired. FIG. 9is illustrative of an example of a completed socket 30 constructed toinclude the one or more reinforcing rings 304 (a plurality ofreinforcing rings along the length of the socket 30 as shown).

In the examples above, the socket 30 is configured with the ability forone or more portions of the socket 30 to be expanded to an expandeddiameter and then resiliently recover from such expansion. Although suchexamples address this feature via incorporation of elasticallyrecoverable stent-like structure(s), the socket 30 may incorporateadditional or alternative features to achieve such resilient retractionfollowing diametric expansion. For example, materials of the socket 30may have elastomeric materials included in one or more layers ofmaterial forming the socket 30 such that the socket 30 exhibits theability to be diametrically distended and then elastically recover. Oneoption includes forming one or more layers of the socket 30 of anelastomeric material (e.g., FEP). Another option would includeincorporating an elastomeric material into one or more layers of thesocket 30 (e.g., by coating or imbibing an expandable substratematerial, such as ePTFE with an elastomeric material).

In terms of assembly and potential advantages of incorporating elasticrecovery properties, FIG. 10 is illustrative of how the socket 30 may beassembled to the first component 22 leveraging such elastic recoveryproperties. As shown, the socket 30 may be distended, or expanded as itis passed over the first component 22. Portions of the socket 30 on thelarger diameter first component 22 then actively engage, or are biasedagainst the first component 22. Additionally or alternatively, portionsof the socket 30 that are allowed to return to a smaller diameter afterbeing distended help retain, or secure the socket 30 to the firstcomponent. In particular, one or more portion(s) of the socket 30 neckdown, or recover to a smaller diameter than adjacent portion(s) of thefirst component 22, thereby securing the socket 30 in place.

The materials implemented for any of the foregoing examples of thesocket 30, may be configured to exhibit desired mechanical propertiesand/or to produce a desired response from the bodily environment. Insome examples, the socket 30 includes one or more layer(s) oflongitudinally-oriented material for axial, or column strength. Forexample, the layer(s) may include an expanded fluoropolymer with amicrostructure that is oriented to provide longitudinal strength. Onesuch material may include an expanded fluoropolymer (e.g., ePTFE) with afibril structure that is oriented longitudinally relative to the socket30 to enhance longitudinal, or column strength of the socket 30. Thematerials of the socket may also include one or more layer(s) ofcircumferentially-oriented material for radial, or hoop strength. Forexample, the socket 30 may include one or more layer(s) ofcircumferentially-oriented material for radial, or hoop strength. Forexample, the layer(s) may include an expanded fluoropolymer with amicrostructure that is oriented to provide radial or hoop strength. Onesuch material may include an expanded fluoropolymer (e.g., ePTFE) with afibril structure that is oriented circumferentially relative to thesocket 30 to enhance radial or hoop strength of the socket 30.Additionally or alternatively, such layer(s) may be combined, or mayinclude multiple orientations (e.g., both longitudinal andcircumferential) in order to achieve desired characteristics.

Additionally or alternatively, the microstructure of one or moreinterior or exterior layer(s) may be oriented to promote wear andabrasion resistance. For example, where abrasion is likely to beencountered in a longitudinal direction relative to the socket 30, anexpanded fluoropolymer such as ePTFE with a fibril microstructure mayhave the fibrils oriented in the longitudinal direction—i.e., in thedirection of wear or abrasion. This may be particularly advantageous inthe example of a uniaxially oriented fibril microstructure.Additionally, a relatively more dense (e.g., less porous) microstructuremay be employed to enhance overall wear and abrasion resistant of inneror outer layers of the socket 30. Abrasion and wear resistance of thesocket 30 may be promoted via other additional or alternative features.For example, an abrasion resistant coating may be applied to an exterioror interior surface of the socket 30. One such coating may be acopolymer of Tetrafluoroethylene (TFE) and Perfluoromethylvinylether(PMVE). As another example of a wear/abrasion resistant coating, ahydrophilic and/or lubricious material may be employed, such as ahydrogel coating. These are just some examples, and other wear resistantfeatures that may be employed in addition to, or as an alternative toabrasion-, or wear-resistant microstructures.

In view of at least the foregoing, various examples include thematerials forming the socket 30 promoting tissue ingrowth (e.g., toreduce thrombosis or help secure the multicomponent implantable device10 at a desired implant location). Additionally, in someimplementations, materials forming the socket 30 include a filmmicrostructure in which fibrillar orientation is in a directionsubstantially parallel the longitudinal axis of socket 30. Such aconfiguration can help ensure that longitudinal motion of one or more oreach of the plurality of components 20 (e.g., anchor components, tethercomponents, and/or tether lock components) will be aligned with thefibrillar orientation to help reduce friction and/or wear on thecomponent(s).

In various examples, the socket 30 may be formed from a material setincluding ePTFE graft material, elastomer material, other polymericmaterial, or combinations of such materials. In some embodiments, thesocket 30 is constructed from ePTFE stretch graft material, such asmaterial similar to that available from W.L. Gore & Associates, Inc.under the trade name “GORE-TEX” brand “Stretch Vascular Grafts.” Thesocket 30 may include material modified to enhance column strength(e.g., by including one or more layers of material that are relativelydenser, or less porous). The socket 30 may also include materials thatare partially or fully bio-resorbable or bio-absorbable. In suchexamples, the socket 30 can be configured to provide temporary fixation(e.g., between component(s) and or with the body) which degradespartially or fully over time.

In some embodiments, the socket 30 includes one or more layersconfigured as a mesh, or network of material, that is adapted to enhancebiocompatibility and fibrosis following implantation. Such mesh ornetwork may be formed by crossing strands of material, or by formingintermittent voids or openings in a layer of material. Such mesh ornetwork configurations may be implemented to promote tissue growth ontoand/or through the mesh or network surface. In some examples, tissuegrowth may be promoted by incorporating a relatively rough and/or porousouter and/or inner surface into the socket 30. If desired, one or moreholes may be formed into or through the socket material, which maypromote the formation of scar tissue fibrocytes (e.g., to promote strongfixation to tissue).

It should be understood that the other component(s) of the implantabledevice 10 may employ similar features to enhance wear or abrasionresistance of those components. For example, as previously referenced,the second component 24 may be configured as a tether component formedof a relatively flexible, elongate material (e.g., monofilament,multifilament, braided, or other material). Where abrasion is likely tobe encountered in a longitudinal direction relative to the socket 30, anexpanded fluoropolymer such as ePTFE with a fibril microstructure mayhave the fibrils oriented in the longitudinal direction—i.e., in thedirection of wear or abrasion. Again, this may be particularlyadvantageous in the example of a uniaxially oriented fibrilmicrostructure. Again, a relatively more dense (e.g., less porous)microstructure may be employed (e.g., a relatively more dense ePTFE orexpanded (fluoro)polymer) to enhance overall wear and abrasion resistantof the second component 24.

Similarly to the socket 30, abrasion and wear resistance may also bepromoted via other additional or alternative features. For example, anabrasion resistant coating may be applied to the second component 24.One such coating may be a copolymer of Tetrafluoroethylene (TFE) andPerfluoromethylvinylether (PMVE). As another example of a wear/abrasionresistant coating, a hydrophilic and/or lubricious material may beemployed, such as a hydrogel coating. Again, these are just someexamples, and other wear resistant features that may be employed inaddition to, or as an alternative to abrasion-, or wear-resistantmicrostructures. It should also be understood that similar principalsmay be applied to the other components of the implantable device 10,such as the fourth component 28.

In some examples, one or more layer(s) of the socket 30 may be formed ofa material having a desired permeability. For example, in some examplesthe socket includes one or more layers that are impermeable to cellularintegration, or which are impermeable to body fluids such as blood orblood serum, to improve overall mechanical characteristics and/orbiologic response as desired.

In some examples, the outermost layer(s) may have an internodal distanceor spacing of greater than or equal to 6 micrometers.

In some examples, the outermost layer(s), or exposed surface layer(s),may be configured to achieve one or more tiers within a range ofbiologic, or foreign body responses.

A first tier of foreign body responses (e.g., at a first relativematerial porosity) would include impermeability to blood plasma andserum.

A second tier of foreign body responses (e.g., at a second relativematerial porosity) would include plasma and/or serum infiltration intothe exposed surface.

A third tier of foreign body responses (e.g., at a third, higherrelative material porosity) would include minimal, or some level ofextracellular matrix integration.

A fourth tier of foreign body response (e.g., at a fourth, even higherrelative material porosity) would include cellular integration.

A fifth tier of foreign body responses (e.g., at a fifth, highestrelative material porosity) would include vascular integration,including full tissue ingrowth and blood vessels supplying the tissue.The outermost, or exposed surface(s) can be tailored to exhibit any ofthese relative tiers of foreign body responses as desired, for exampleby selecting material microstructure, coatings, and/or surfacetreatments.

An assessment of whether or not the material is exhibiting a particulartier of foreign body response may be made using a variety of techniques.Measurement techniques for assessing the presence of one or more tiersof foreign body response could include a permeability test such as thosedescribed according to ASTM standards. In various examples, a histologyassessment may be an appropriate tool for assessing foreign bodyresponses under any of the various tiers previously described.

The foreign body response of the outermost layer or surface may beadditionally or alternatively tailored through the use of coatingsand/or surface treatments. For example, the outermost layer(s) may betreated with heparin bonding (e.g., including that sold under thetradename “CBAS” by W.L. Gore & Associates, Inc. and Carmeda AB, whichis a heparin bonding technology for lasting thromboresistance). Asanother example, the socket 30 may be tailored to include one or moreeluting technologies, such as drug elution technologies. Any of avariety of biological coatings can be included on the outer and/or innersurfaces of the socket 30 to achieve a desired biologic response,including promoting healing and/or tissue growth, for example.

As previously referenced, the socket 30 and any of the foregoingfeatures and examples thereof may be applied in a variety of devicecontexts. For example, FIG. 11 shows another implantable device 410utilizing the socket 30, according to some examples. As shown, theimplantable device 410 includes a plurality of components 420, such as afirst component 422, a second component 424, and socket 30 extendingover the first component 422 and the second component 424. The socket 30is again generally configured to enhance inter-component and/orinter-environment interactions of an implantable device. For ease ofillustration and visualization of the underlying components, the socket30 is again illustrated generically in a see-through manner, designatedby broken lines.

The implantable device 410 in the example of FIG. 11 is an implantableblood pump, such as a left ventricular assist device (LVAD) configuredfor implantation in the body of a patient (not shown). As shown, thefirst component 422 is optionally a pump apparatus and the secondcomponent 424 is a lead (e.g., an electrical or mechanical connector)extending from the first component 422 (e.g., for powering orcontrolling the pump apparatus). The first component 422 includes a body440 and an impeller and motor subassembly 442 housed, or maintained bythe body 440. The implantable device 410 is shown generically in FIG. 11, and can be any of a variety of blood pump designs with any of avariety of components that would benefit from use of the socket 30. Asshown, the socket 30 may assist with maintaining a physical position ofthe second component 424 relative to the first component 422 (e.g., toavoid unwanted flexing or movement at the interface between the firstand second components 422, 424). The socket 30 may additionally oralternatively promote any of the inter-environment interactionsmentioned in association with any of the other examples described herein(e.g., impermeability, reduced thrombosis, tissue ingrowth, preventionof tissue ingrowth, and combinations thereof, or others).

Various methods of treatment using the implantable devices of any of thepreceding examples include delivering the implantable device to alocation in a body of a patient (e.g., into a heart of a patient). Invarious examples, another component (e.g., the third component 26) isreceived in the socket 30 in vivo (e.g., by being slid into the socket30 as part of a tensioning or other process in association with atranscatheter mitral chordal repair method).

Although the various examples above are cast in the context of animplantable device, the various concepts and features above may also beapplied in the context of a single component as desired. For theavoidance of doubt, the scope of invention is not limited tomulti-component implantable devices. Specifically, in some examples, thesocket 30 may be implemented in association with a single component, andneed not be configured to and/or actually receive any additional,discrete components. For example, the socket 30 can be used to helpsmooth, or reduce radial profile variability. Transverse elements of thecomponent that protrude relative to a surrounding portion of the outerprofile could result in thrombosis, or damage to surrounding tissue, forexample.

FIG. 12 shows an implantable device 510 including a first component 522having a first outer profile defining first radial variability along thefirst component. The first component 522 also includes an optionalradial projection 524 that is integral to the first component (e.g., anintegral anchor, antennae, or other feature) that projects transverselyand defines a portion of the first outer profile and the associatedradial variability of the first outer profile. The first component 522could be an implantable sensor, a blood pump, or other device asdesired. As shown, the implantable device 510 includes socket 30extending over the first outer profile of the first component 524 todefine a second outer profile having a second radial variability that isreduced relative to the first radial variability. In other words, theouter profile of the first component 524, including the optional, radialprojection 524 has been smoothed out by the socket 30, such the radialvariability of the first outer profile is reduced. Similarly to otherexamples, the socket 30 optionally includes one or more outer exposedsurfaces configured to exhibit one or more tiers of foreign bodyresponses within a range of possible foreign body responses.

Inventive concepts of this application have been described above bothgenerically and with regard to specific embodiments/examples. It will beapparent to those skilled in the art that various modifications andvariations can be made in the embodiments without departing from thescope of the disclosure. Thus, it is intended that the embodiments coverthe modifications and variations of this invention provided they comewithin the scope of the appended claims and their equivalents.

What is claimed is:
 1. An implantable device comprising: a firstcomponent having a first outer profile defining first radial variabilityalong the first component; and a socket extending over the first outerprofile of the first component to define a second outer profile having asecond radial variability that is reduced relative to the first radialvariability, wherein the socket includes one or more outer exposedsurfaces having one or more material porosities, wherein the socket isformed of one or more layers of material including a fibrilmicrostructure in which an orientation of the fibril microstructure isin a direction aligned to a longitudinal axis of socket.
 2. Theimplantable device of claim 1, wherein the one or more outer exposedsurfaces having the one or more material porosities configured toexhibit extracellular matrix integration.
 3. The implantable device ofclaim 1, wherein the socket includes one or more layers of material thatis impermeable to cellular integration.
 4. The implantable device ofclaim 1, wherein the socket includes one or more reinforcing rings. 5.The implantable device of claim 4, wherein at least one of the one ormore reinforcing rings is elastically deformable to an enlarged diameterfrom which the one or more reinforcing rings elastically recovers. 6.The implantable device of claim 5, wherein the one or more reinforcingrings defines a continuous, helical undulating pattern.
 7. Theimplantable device of claim 1, wherein the socket includes an outwardlyflared end.
 8. The implantable device of claim 1, wherein the socketincludes a reinforced end.
 9. The implantable device of claim 1, whereinat least one of an outer and an inner surface of the socket includesmaterial configured to promote tissue ingrowth.
 10. The implantabledevice of claim 1, wherein the socket is formed from a material setincluding ePTFE graft material, elastomer material, other polymericmaterial, or a combination of two or more such materials.
 11. Theimplantable device of claim 1, wherein the socket includes an ePTFEstretch graft material.
 12. The implantable device of claim 1, whereinthe socket includes material that is partially or fully bio-resorbableand/or partially or fully bio-absorbable.
 13. The implantable device ofclaim 1, wherein the socket includes materials that are partially orfully bio-resorbable or bio-absorbable and is configured to providetemporary fixation to body tissue that degrades partially or fully overtime.
 14. The implantable device of claim 1, wherein the socket includesone or more layers configured as a mesh or network of material that isadapted to enhance biocompatibility and fibrosis following implantation.15. The implantable device of claim 14, wherein the mesh or network ofmaterial is formed by crossing strands of material or by intermittentvoids or openings in one or more layers of material.
 16. The implantabledevice of claim 1, configured as a transcatheter mitral chordal repairdevice or a blood pump device.
 17. An implantable device comprising: afirst component; a second component flexibly coupled to the firstcomponent; a socket extending over the first component and the secondcomponent, the socket being configured to enhance an inter-componentinteraction between the first and second components of the implantabledevice by holding the second component in position and reducing relativemovement between the first and second components, wherein the socketincludes one or more outer exposed surfaces having one or more materialporosities, the one or more outer exposed surfaces configured to exhibitone or more tiers of foreign body responses within a range of possibleforeign body responses; and a third component and fourth component, thesocket being configured to receive the third and fourth components toenhance an inter-component interaction between the first and thirdcomponents of the implantable device, wherein the third component is atether lock component and the fourth component is a tether component.18. The implantable device of claim 17, wherein the first component isan anchor component and the second component is a tether component. 19.A method comprising: delivering a multi-component device to a locationin a body of a patient, the multi-component device including a firstcomponent having a first outer profile defining first radial variabilityalong the first component; and a socket extending over the first outerprofile of the first component to define a second outer profile having asecond radial variability that is reduced relative to the first radialvariability, wherein the socket includes one or more outer exposedsurfaces having one or more material porosities, wherein the socket isformed of one or more layers of material including a fibrilmicrostructure in which an orientation of the fibril microstructure isin a direction aligned to a longitudinal axis of socket; and inserting athird component into the socket to enhance the inter-componentinteraction between the first and third components of the implantabledevice.
 20. The method of claim 19, wherein the third component is atether lock component.